Left Atrial Appendage Closure Versus Direct Oral Anticoagulants in High-Risk Patients With Atrial Fibrillation

JOURNAL OF THE AMERICAN COLLEGE OF CARDIOLOGY

卷:75

Article

Osmancik, Pavel^1,2  Herman, Dalibor^1,2  Neuzil, Petr³  Hala, Pavel³  Taborsky, Milos⁴  Kala, Petr^5,6  Poloczek, Martin^5,6  Stasek, Josef⁷  Haman, Ludek⁷  Branny, Marian⁸  Chovancik, Jan⁸  Cervinka, Pavel^9,10  Holy, Jiri^9,10  Kovarnik, Tomas¹¹  Zemanek, David¹¹  Havranek, Stepan¹¹  Vancura, Vlastimil^12,13  Opatrny, Jan^12,13  Peichl, Petr¹⁴  Tousek, Petr^1,2  Lekesova, Veronika³  Jarkovsky, Jiri¹⁵  Novackova, Martina¹⁵  Benesova, Klara¹⁵  Widimsky, Petr^1,2  Reddy, Vivek Y.^3,16 

[1] Charles Univ Prague, Fac Med 3, Cardioctr, Prague, Czech Republic

[2] Univ Hosp Kralovske Vinohrady, Prague, Czech Republic

[3] Na Homolce Hosp, Cardioctr, Dept Cardiol, Prague, Czech Republic

[4] Univ Hosp Olomouc, Cardioctr, Dept Cardiol, Olomouc, Czech Republic

[5] Masaryk Univ, Clin Cardiol, Brno, Czech Republic

[6] Univ Hosp Brno, Brno, Czech Republic

[7] Charles Univ Prague, Univ Hosp Hradec Kralove, Fac Med, Dept Internal Med 1, Prague, Czech Republic

[8] Hosp Podlesi As, Cardioctr, Dept Cardiol, Trinec, Czech Republic

[9] Masaryk Hosp, Dept Cardiol, Krajska Zdravotni As, Usti Nad Labem, Czech Republic

[10] Univ JE Purkyne, Usti Nad Labem, Czech Republic

[11] Charles Univ Prague, Gen Fac Hosp, Cardioctr, Internal ClinicCardiol & Angiol 2, Prague, Czech Republic

[12] Univ Hosp, Dept Cardiol, Plzen, Czech Republic

[13] Fac Med Pilsen, Plzen, Czech Republic

[14] Inst Clin & Expt Med, Cardioctr, Prague, Czech Republic

[15] Masaryk Univ, Inst Biostat & Anal, Brno, Czech Republic

[16] Icahn Sch Med Mt Sinai, Helmsley Electrophysiol Ctr, One Gustave L Levy Pl,Box 1030, New York, NY 10029 USA

关键词: atrial fibrillation;    cardioembolic event;    direct oral anticoagulant;    left atrial appendage;    stroke;   

DOI  :  10.1016/j.jacc.2020.04.067

来源: Elsevier

【 摘 要 】

BACKGROUND Percutaneous left atrial appendage closure (LAAC) is noninferior to vitamin K antagonists (VKAs) for preventing atrial fibrillation (AF)-related stroke. However, direct oral anticoagulants (DOACs) have an improved safety profile over VKAs, and their effect on cardiovascular and neurological outcomes relative to LAAC is unknown. OBJECTIVES This study sought to compare DOACs with LAAC in high-risk patients with AF. METHODS Left Atrial Appendage Closure vs. Novel Anticoagulation Agents in Atrial Fibrillation (PRAGUE-17) was a multicenter, randomized, noninferiority trial comparing LAAC with DOACs. Patients were eligible to be enrolled if they had nonvalvular AF; were indicated for oral anticoagulation (OAC); and had a history of bleeding requiring intervention or hospitalization, a history of a cardioembolic event while taking an OAC, and/or a CHA(2)DS(2)-VASc of >= 3 and HAS-BLED of >2. Patients were randomized to receive LAAC or DOAC. The primary composite outcome was stroke, transient ischemic attack, systemic embolism, cardiovascular death, major or nonmajor clinically relevant bleeding, or procedure-/device-related complications. The primary analysis was by modified intention to treat. RESULTS A high-risk patient cohort (CHA(2)DS(2)-VASc: 4.7 +/- 1.5) was randomized to receive LAAC (n = 201) or DOAC (n = 201). LAAC was successful in 181 of 201 (90.0%) patients. In the DOAC group, apixaban was most frequently used (192 of 201; 95.5%). At a median 19.9 months of follow-up, the annual rates of the primary outcome were 10.99% with LAAC and 13.42% with DOAC (subdistribution hazard ratio [sHR]: 0.84; 95% confidence interval [CI]: 0.53 to 1.31; p = 0.44; p = 0.004 for noninferiority). There were no differences between groups for the components of the composite endpoint: all-stroke/TIA (sHR: 1.00; 95% CI: 0.40 to 2.51), clinically significant bleeding (sHR: 0.81; 95% CI: 0.44 to 1.52), and cardiovascular death (sHR: 0.75; 95% CI: 0.34 to 1.62). Major LAAC-related complications occurred in 9 (4.5%) patients. CONCLUSIONS Among patients at high risk for stroke and increased risk of bleeding, LAAC was noninferior to DOAC in preventing major AF-related cardiovascular, neurological, and bleeding events. (Left Atrial Appendage Closure vs. Novel Anticoagulation Agents in Atrial Fibrillation [PRAGUE-17]; NCT02426944) (C) 2020 by the American College of Cardiology Foundation.

【 授权许可】

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